A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-Line Chemotherapy
18 Years
N/A
Female
Epithelial Ovarian Cancer
Trial Information
A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-Line Chemotherapy
This study proposes a nontoxic immunotherapeutic approach to extend the progression free
interval following first-line treatment in patients in complete remission.
Most patients with ovarian cancer achieve complete clinical remission after optimal
debulking surgery and platinum-based chemotherapy. However, most patients, despite high
response rates to first-line treatment, will relapse and undergo subsequent lines of
chemotherapy. Generally, the progression-free interval between treatments becomes shorter
with each relapse, and the patient eventually dies of the disease. The ability to increase
the progression-free intervals between chemotherapeutic treatments would have a significant
benefit to a patient's quality of life and would potentially lead to longer overall
survival.
Inclusion Criteria:
- A confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or
fallopian tube cancer
- Have undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor
- Eligible for, and plan to undergo standard platinum and taxane first-line
chemotherapy
- Mucin 1-positive tumor as determined by central immunohistopathology
- Adequate renal function
- Adequate liver function
- Adequate bone marrow function
- Life expectancy of at least 12 months at the time of screening as judged by the
investigator
Exclusion Criteria:
- Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Mullerian
tumors, or mucinous carcinoma of the peritoneum
- Malignancy other than EOC, except those that have been in CR for a minimum of 3
years, and except carcinoma in-situ of the cervix or basal cell and squamous cell
carcinomas of the skin that have been adequately treated
- Evidence of severe or uncontrolled cardiac disease
- Active uncontrolled infection
- Uncontrolled hypertension
- Diagnosed immunodeficiency or autoimmune disorder
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy
Outcome Description:
PFS is defined as the time from randomization to the date of radiological scan used to determine PD, evaluated every 8 weeks after baseline.
Outcome Time Frame:
From date of randomization until the date of first documented progression, date of death from any cause, or end of study, whichever comes first, assessed up to 156 weeks
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
CAN-004
NCT ID:
NCT01521143
Start Date:
January 2012
Completion Date:
December 2015
Related Keywords:
- Epithelial Ovarian Cancer
- EOC
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| California Cancer Center | Fresno, California 93720 |
| Sarasota Memorial Hospital | Sarasota, Florida 34239 |
| Stanford University School of Medicine | Stanford, California 94305-5317 |
| University of California, San Francisco | San Francisco, California 94143 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Memorial Health University Medical Center | Savannah, Georgia 31404 |
| LAC-USC Medical Center | Los Angeles, California 90033 |
| Swedish Cancer Center | Seattle, Washington 98122 |
| Collaborative Research Group | Boynton Beach, Florida 33435 |
| Innovative Clinical Research Institute | Downey, California 90241 |
| St Joseph Hospital | Orange, California 92868 |
| University Gynecologic Oncology | Atlanta, Georgia 30342 |
| Women`s Cancer Center | Morristown, New Jersey 07962 |
| Portland Medical Group | Portland, Oregon 97213 |
